Clinical Trials
Introduction to Clinical Trials
Clinical trials are research studies designed to find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. Through participation in these trials, you may receive access to new and investigational therapy options that are not available to women outside the clinical trial setting. Clinical trial designs are all screened, approved, and monitored by national health authorities, and patients who enroll in clinical trials must be treated with the best available care. Some clinical trials only enroll patients with specific disease characteristics, so it is important to note that you may not be eligible for participation in such programs.
Many women undergoing treatment for ovarian cancer choose to participate in clinical trials. Clinical trials are research studies in which people (who volunteer) help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and find better ways to prevent, screen for, diagnose or treat cancer.
Today, clinical trials are conducted in most hospitals and cancer treatment centers across the U.S. To ensure the reliability of the data and the safety of all participating patients, all clinical trial researchers conduct their studies under the strict guidelines of the U.S. Food and Drug Administration (the FDA).
Should You Participate in A Clinical Trial?
Whether you should join a clinical trial requires a lot of thought and consideration and is a decision that should make in close consultation with your healthcare team and your loved ones.
Keep in mind:
• Clinical trials are only open to people who meet very specific medical requirements; every person is not eligible for each clinical trial.
• Clinical trial participants can be among the first to receive new treatments before they hit the market. But remember, these treatments are under investigation and may have potential side effects.
• It is your right to withdraw from a clinical trial at any time.
• For many women with ovarian cancer, especially those experiencing resistant or recurrent ovarian cancer, investigational treatments can offer new hope.
It is important to ask questions before deciding to enter a clinical trial. Some questions to ask your doctor and the clinical trial staff include:
• What is the purpose of the study?
• Who is conducting the trial?
• Am I eligible to participate?
• What type of treatments or tests will I have to take?
• Why do the researchers think the treatment being tested may be effective?
• Has the treatment been tested before?
• What are the benefits and risks of participation?
• Does the treatment have side effects?
• How long will the study last?
• Will my insurance cover the costs?
• Can my doctor stay involved?
Clinical Trial Resources: Where Do I Begin?
Following are some helpful resources that will help you learn more about clinical trials and find trials that might be appropriate for you.
Cancer Trials Support Unit
1-888-823-5923
www.ctsu.org
The Cancer Trials Support Unit is a pilot project sponsored by the National Cancer Institute (NCI) to make NCI-supported cancer treatment trials available to physicians nationwide.
Coalition of National Cancer Cooperative Groups
1-877-520-4457
www.cancertrialshelp.org
The Coalition of National Cancer Cooperative Groups is comprised of cancer clinical trial specialists and offers a variety of programs and information for physicians, patient advocate groups and patients. These programs are designed to increase awareness of, and participation in, cancer clinical trials.
National Cancer Institute
1-800-4-CANCER
http://ccr.nci.nih.gov/trials
The cancer-specific arm of the U.S. National Institutes of Health, this site offers comprehensive information about cancer clinical trials.
The following internet sites provide additional valuable information for women considering participating in a trial: Acurian: www.acurian.com
Gynecologic Oncology Group: www.gog.org
MD Anderson: http://www.mdanderson.org/site_map/
Cancer Trials Support Unit (CTSU)
A Web Based System That Offers Efficient and Effective Tools for Clinical Trials Management.
In 1996, the National Cancer Institute (NCI) and its Board of Scientific Advisors convened the Clinical Trials Program Review Group to evaluate NCI-sponsored, extramural clinical trial programs. Based on the Review Group’s recommendations, the NCI created a pilot project called the Cancer Trials Support Unit (CTSU).
The CTSU aims to increase physician and patient access to Phase III cancer treatment trials, most of which are led by the Clinical Trials Cooperative Groups. One of the ways the CTSU accomplishes this is through providing cross-Group access to selected Phase III NCI-sponsored trials. This means Cooperative Group members are able to enroll eligible patients for any CTSU trial that is not available through their own Cooperative Group. Currently, the CTSU has 40 active studies and 40 studies in development. Initially, the CTSU protocol menu included protocols from 5 disease areas - gastrointestinal, genitourinary, lung, breast, and adult leukemia; however, the CTSU has expanded to include other diseases such as melanoma, head & neck, multiple myeloma, and some rare cancers.
Beginning May 18, 2002, the CTSU opened its protocol menu to qualified medical, radiation, and surgical oncologists and hematologists within the USA who are not Cooperative Group members. The new policy allows cancer patients anywhere in the USA to participate more easily in advanced (Phase III) treatment trials. More information can be accessed on the public side of the CTSU web site (http://www.ctsu.org).
A unique aspect of the CTSU is its foundation in the web. All CTSU members have access to protocols, protocol-specific forms, and patient educational materials on the members’ side of the CTSU web site (http://members.ctsu.org/). Protocol-specific materials that are provided on-line include the following: IRB submission application template, protocol overview, protocol-specific time and events schedule, protocol instructions, a pocket-sized protocol card that outlines the eligibility requirements and treatment plan and Patient Education Pages (PEPs) that explains patients options for treatment in a patient-friendly language.
An important benefit of the CTSU has been the availability of several web-based educational offerings. These training programs and tools can facilitate the enrollment of patients on CTSU trials. The CTSU offers an on-line educational program that can be accessed via the public side of the web site (http://www.ctsu.org) called eCourse. This program provides both novice and experienced research staff with a convenient method of learning about participation in clinical trials through the CTSU. A CTSU process checklist is also available on the web site as an easy-to-follow flowsheet that provides instructions on how to successfully register and enroll a patient via the CTSU. A Frequently Asked Questions (FAQ’s) link offers answers to common questions about the CTSU.
Also, the CTSU offers a Patients Page on the public side of the web site. This page contains resources specifically for patients seeking information about cancer and available clinical trials, including links to: NCI web sites that offer disease-specific, treatment, and support information for patients, information on health insurance with links to many of the major providers, a printable list of all currently active protocols on the CTSU menu, Cooperative Group web sites, and protocol abstracts from the National Cancer Institute’s PDQ database, including access to patient and health professional versions of the abstracts.
For more information, visit the CTSU web site at www.ctsu.org, contact the CTSU Help Desk at 1-800-823-5923 or by email at CTSUContact@westat.com.
A growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care you receive as a participant in a clinical trial.
"Routine patient care costs" are the usual costs of medical care, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., that you would receive whether or not you were participating in a clinical trial. Some health plans don’t cover these costs once you join a trial, even though studies have shown that they are not appreciably higher than costs for patients who are not enrolled in trials. For information, please click on
EmergingMed Clinical Trial Service
EmergingMed is a confidential, secure, and free service to help you find and gain access to clinical trials that are testing new therapies for ovarian cancer. A single short, anonymous questionnaire - easily answered by patients and family members - is compared against the enrollment criteria for ALL of the clinical trials in the EmergingMed database in seconds. The resulting short list of clinical trials you might be eligible for can be printed out and discussed with your doctor. When you decide which of those trials you wish to pursue, EmergingMed will help you contact the right person at the location where the trial is being administered. Please be sure and read EmergingMed’s Privacy Policy.
TELCYTA™ (TLK286)
ASSIST-3 is a randomized Phase 3 study designed to enroll 244 women with 122 to be treated with the combination of TELCYTA plus carboplatin, and 122 to be treated with Doxil®. The trial endpoints are objective response
rate, progression-free survival and overall survival. The study is based on a positive multicenter Phase 2 study of the combination of TELCYTA plus carboplatin in platinum refractory or resistant ovarian cancer, first presented at the annual meeting of the American Society of Clinical Oncology last year and later updated at the Tenth Biennial International Gynecologic Cancer Society meeting. The initial participating institutions are the Harvard Affiliated Hospitals including the Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Beth Israel Deaconess Medical Center. More information about the trial is available at www.ASSIST-Ovarian.com or by calling 866-4TLK286.
Telik, Inc. presented interim data on two Phase 2 clinical trials studying its novel investigational drug TELCYTA in combination with approved drugs commonly used in ovarian cancer at the American Society of Clinical Oncologists (ASCO) in New Orleans on June 5, 2004.
Phase 2 Dose-Ranging Study of TLK286 in Combination with Carboplatin in Platinum Refractory or Resistant Ovarian Cancer - Data was reported on 16 patients enrolled in the trial. All patients’ ovarian cancers were refractory or resistant to platinum-based treatment. Three patients achieved complete responses (CRs) and 6 patients have partial responses (PRs) for an objective response rate (ORR) of 56%. An additional 5 patients achieved stable disease (SD) for a combined (ORR+SD) disease stabilization rate (DSR) of 88%. TELCYTA in combination with carboplatin has been well tolerated with no unexpected or cumulative toxicities observed.
TELCYTA is a cancer cell-activated chemotherapeutic agent activated by an enzyme that is present in higher levels in many human cancers, including ovarian cancer. Since TELCYTA is preferentially activated in cancer cells, it may offer a more selective and directed therapy. Laboratory studies suggest that TELCYTA combined with other chemotherapy agents may work better than each drug alone.
Telik, Inc. is a Palo Alto, California-based biopharmaceutical company focused on developing small molecule drugs for the treatment of cancer. Telik’s website is www.telik.com.
OvaRex® MAb (oregovomab) Phase III Clinical Trial is Enrolling
OvaRex® MAb (oregovomab) is a Phase III clinical trial is for women who have been diagnosed with Stage III/Stage IV ovarian cancer. OvaRex is a monoclonal antibody that targets CA125, a marker found in the blood associated with ovarian cancer. OvaRex is designed to help each patient’s immune system recognize ovarian cancer cells and fight their disease. For more information, visit www.OvaRex.com.
Ascities Trial Currently Enrolling Phase II
A Phase II study of an investigational drug called catumaxomab. You may be able to participate in this study if you have abdominal fluid build-up (ascites) due to ovarian cancer requiring frequent drainage (paracentesis). This study will test whether four doses of catumaxomab given intraperitoneally (into the abdomen) will delay the need for paracentesis. Approximately 35 patients will be enrolled at multiple centers in the United States.
Catumaxomab belongs to a new type of antibodies called trifunctional antibodies. Catumaxomab works by attaching to a protein on ovarian cancer cells called Epithelial Cell Adhesion Molecule (EpCAM). Catumaxomab also attaches to white blood cells which are cells that help protect the body against infection and foreign materials and the development of cancer. It is hoped that catumaxomab can kill cancer cells by bringing white blood cells together with cancer cells and thus fighting the cause of ascites in ovarian cancer.
For more information regarding this study, including participating locations, please email Fresenius Biotech at: clinicaltrials@fresenius-biotech.com or visit www.clinicaltrials.gov (keyword: catumaxomab). This trial is sponsored by Fresenius Biotech North America, Inc. based in Lexington, Massachusetts. Protocol Number: IP-REM-AC-02-US.
OMNITARGTM Phase II Clinical Trial is Currently Enrolling - Genentech, Inc. is currently enrolling patients into a Phase II clinical trial that
will evaluate the efficacy of OmnitargTM (Pertuzumab, rhuMAb 2C4) in combination with Gemcitabine chemotherapy in treating women with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
Omnitarg is an antibody that is designed to inhibit tumor growth by targeting the interaction of the HER receptor proteins (HER1/EGFR, HER2, HER3 and HER4). Omnitarg represents the first in a new class of targeted potential agents known as HER dimerization inhibitors (HDIs).
How is the study designed?
It is expected that there will be over 130 patients enrolling in approximately 40 sites throughout the United States for this study.
This is a double-blind study and participants will be randomized to one of two treatment arms:
· A control arm (Gemcitabine + placebo); or,
· A treatment arm (Gemcitabine + Omnitarg)
All participants will be closely monitored. If a participant’s cancer progresses while she is receiving Gemcitabine + placebo, she will have the opportunity to “crossover” to receive Gemcitabine + Omnitarg. In this way, any woman whose cancer has progressed while taking the placebo will have the opportunity to receive Omnitarg. The primary endpoints for the trial are progression-free survival and safety/tolerability. In addition, this study will evaluate HER2 status in the tumors of participants, so women will need to provide tumor tissue specimens in paraffin blocks or at least 12 unstained slides with an associated pathology report. These specimens may have been obtained at any time prior to entry in the study.
Who is eligible for the trial?
| Key eligibility criteria: | Key exclusion criteria: |
| § Women = 18 years of age § Advanced, histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma § Platinum-resistant or refractory carcinoma § Life expectancy = 12 weeks | § Prior treatment with Gemcitabine § Three or more prior chemotherapeutic regimens § Prior treatment with experimental anti-cancer agents within the 4 weeks prior to the first day of treatment in the study § Prior treatment with HER2 pathway inhibitors, e.g., Herceptin® (Trastuzumab), IressaTM (gefitinib), TarcevaTM(erlotinib HCl) § History or clinical evidence of central nervous system or brain metastases § History of serious systemic disease, unstable angina, myocardial infarction within the 6 months prior to Day 1 of treatment § Symptoms of congestive heart failure or unstable symptomatic arrhythmia, requiring medication |
Site Enrollment
The trial is currently open for enrollment in the following three sites, and will be expanding to many more sites in the near future. To enroll, you must first call the Trial Information Support Line at 888-662-6728 to initiate the process.
Northern Virginia Pelvic Surgery Associates
Annandale, VA
Memorial Health University Medical Center
Savannah, GA
Sutter Cancer Center
Sacramento, CA
Alta Bates Comprehensive Cancer Center
Berkeley, CA
Women & Infants Hospital
Providence, RI
Florida Hospital
Orlando, FL
University of Chicago
Chicago, IL
Norwalk Medical Group
Norwalk, CT
Sharp Healthcare
San Diego, CA
Oklahoma University Medical Center
Oklahoma City, OK
Carolinas Medical Center
Charlotte, NC
Indiana University
Indianapolis, IN
Dana-Farber Cancer Institute
Boston, MA
Mass General Hospital
Boston, MA
North Idaho Cancer Center
Coeur d’Alene, ID
Carilion Gynecology/Oncology
Roanoke, VA
Pelvic Surgery Associates
Columbus, OH
Additional Information
Engaged and informed patient advocates are an important part of the clinical trial process, and Genentech appreciates the opportunity to share information about this Omnitarg Phase II clinical trial with you. For additional information, please visit our Web site at www.gene.com or call our Trial Information Support Line at (888) 662-6728.
NCI and 10 Other Institutions Launch Ovarian Cancer Clinical Trial
The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), is leading a clinical trial designed to build a repository of blood samples in order to develop an accurate means of detecting ovarian cancer soon after the disease returns. Researchers will collect a series of blood samples from women with advanced-stage ovarian cancer who show no signs of cancer after completing their first program of chemotherapy for ovarian cancer.
According to study lead Elise Kohn, M.D., Center for Cancer Research, NCI, “If we can harness all of the protein information in our patient’s samples, we may have a strong lead on how to detect ovarian cancer at an early stage when it can be most effectively treated. CA-125 (a test for a protein that is detectable in 80 percent of advanced stage patients with epithelial ovarian cancer) is currently the only approved test to see if ovarian cancer has returned, but it is not able to reliably diagnose women who have no signs of ovarian cancer.” The scientists’ long-term goal is to make a test that can predict the presence of early stage ovarian cancer using new technology that examines blood proteins. Advanced-stage ovarian cancer has a high likelihood of returning within three years of initial treatment even when there are no signs of cancer being present. Current tests, such as CA-125 and transvaginal ultrasound, do not have good ability to predict whether cancer will return or not or for finding it in the first place. New biomarkers, such as those found in blood, are urgently needed.
The trial will enroll 400 women over 24 months. Researchers are looking for women who have advanced-stage ovarian cancer, have completed their initial chemotherapy within 9 weeks of starting this trial, and show no evidence of cancer following completion of their first treatment program for which they received drugs such as carboplatin or cisplatin with paclitaxel, or docetaxel. The women will have a physical exam and routine laboratory tests performed every three months and a CT scan of the abdomen and pelvis (plus chest if indicated) every six months. Research samples will be frozen to create a repository for analysis of blood proteins. The study will also compare the blood protein test that is developed with CA-125 to see if it is better at predicting return of cancer than CA-125. Additional blood samples will be stored to create a repository so that other promising blood tests for ovarian cancer may be studied.
“A pilot study launched in 2000 gave us a better understanding of the complexities of protein analysis and reinforced the importance of collecting and analyzing a large number of blood samples and their protein patterns. After carefully analyzing our processes and procedures during that pilot study, we now have the opportunity to incorporate those advances and to gather a larger patient pool, expand our partnerships, and make sure that we do not create false-positive results for our patients,” said Kohn. The trial’s leaders note that their goal is to create the best, most accurate, validated test so patients can have a high level of confidence when their results come back.
Ovarian cancer accounts for approximately four percent of all women’s cancers and is the fourth leading cause of cancer-related death among women in the United States, with close to 16,000 women expected to die of the disease in 2005.
For more information or to enroll in the trial at NCI’s Bethesda, Maryland location, please call 1-888-NCI-1937 (1-888-624-1937). Women who are not eligible for this trial but are interested in joining a different clinical trial are invited to contact NCI at 1-800-4-CANCER or go to
www.cancer.gov/clinicaltrials.
The first site opening for this trial is at NCI’s clinical facility on the NIH campus in Bethesda, Maryland. Ten other sites will begin enrolling patients later in 2005 or in 2006. The other participating institutions include:
Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, Wash.
Cedars Sinai Medical Center, Los Angeles, Calif.
University of Alabama at Birmingham
Duke University Medical Center, Durham, N.C.
Fox Chase Cancer Center, Philadelphia, Pa.
University of Texas MD Anderson Cancer Center, Houston, Texas
Massachusetts General Hospital, Boston, Mass.
Northwestern Memorial Hospital, Chicago, Ill.
Evanston Northwestern University Hospital, Evanston, Ill.
New York University School of Medicine, New York, N.Y.
The National Ovarian Cancer Early Detection Program (NOCEDP)
The National Ovarian Cancer Early Detection Program at Northwestern (NOCEDP) provides care and services for asymptomatic women at increased risk of developing ovarian cancer based upon one or more predefined risk factors. The hallmark of the program is the coordinated, multidisciplinary services provided during each comprehensive clinic visit. The purpose of the NOCEDP is to identify those women who are at increased risk for developing ovarian cancer and to develop new tests, unique to the ovaries, to help detect ovarian cancer at an early, treatable stage. The requirements to enroll in the program include one or more of the following:
· A personal history of breast, colon or urinary cancer
· One or more first degree relatives (mother, sister, daughter) with ovarian or breast cancer
· A personal history of a positive BRCA1 or BRCA2 genetic test result
· A close relative with a positive BRCA1or BRCA2 genetic test result.
· The use of fertility drugs for more than one year
Patients receive a physical examination, including pelvic and breast exam, genetic counseling, and an ultrasound. These clinical services are provided by board certified specialists in cancer genetics, gynecologic oncology, and ultrasonography. As part of the research being conducted by the NOCEDP, patients will have blood samples drawn. Using newly identified tumor markers that circulate in the blood of women with advanced stage ovarian cancer, the NOCEDP is developing new blood tests to identify early stage ovarian cancer.
This clinical expertise, together with a National Cancer Institute funded cancer research programs, combine as a state-of-the-art ovarian cancer program available to optimize women’s healthcare. The NOCEDP is located in Tisch Hospital (9R- elevator F) on the campus of the New York University Medical Center in Manhattan. For more information, please visit http://www.med.nyu.edu/nocedp/ or call 212-263-2566Ovarian Cancer Prevention Study Seeks Women
The National Cancer Institute (NCI), in collaboration with the Gynecologic Oncology Group, is funding a new study to identify ways to lower the risk of developing ovarian cancer, as well as to improve the ability to detect the cancer early. Cancer researchers at 63 GOG institutions are now enrolling patients in this new clinical study.
The Ovarian Cancer Prevention and Early Detection Study involves women at elevated risk of developing ovarian cancer because they have a strong family history of breast or ovarian cancer or have tested positive for changes in genes which increase the risk of developing ovarian cancer. The study is evaluating two intervention strategies and, for that reason, participants who join the study are being divided into two groups. One group includes women who choose to have their ovaries and fallopian tubes removed, to determine by how much the preventive surgery decreases the risk of developing ovarian cancer. The second group includes women who elect not to undergo surgery. Rather, these women are being screened for early detection of ovarian cancer, using a new screening technique which is based on frequent blood tests. Upon entering the study, all study participants will complete a series of questionnaires, receive an ultrasound examination of the ovaries, and provide blood samples. Throughout the study, women in each study group will be closely monitored.
Unlike most research studies, the participants in the Ovarian Cancer Prevention and Early Detection Study are able to choose the segment of the study they would like to join. Women may be eligible for the study if they are at least 30 years old, and if they are at an increased risk of ovarian cancer because they or a close relative have a BRCA1 or BRCA2 gene mutation, or because they have a very strong family history of breast and/or ovarian cancer. The Ovarian Cancer Prevention and Early Detection Study plans to evaluate more than 3,400 participants within the next two years.
For more information, or to join the Ovarian Cancer Prevention and Early Detection Study, you may call GOG, at 1-800- 225-3053 to determine the location of the nearest center which has the study open, or visit the study Web site at http://ovariancancer.gog199.cancer.gov
Fox Chase Cancer Center Begins Ovarian Cancer Proteomics Study
to Identify Biologic “Fingerprint” of the Disease
Fox Chase Cancer Center researchers are seeking women who recently have been treated for ovarian cancer to participate in a nationwide effort to find a biologic “fingerprint” of ovarian cancer using a technology called proteomics.
Proteomics is the study of protein patterns in blood or other tissues used to determine cancer probabilities. In a previously published study, researchers used proteomics to successfully differentiate blood samples from women with and without ovarian cancer. This new study is sponsored by the National Cancer Institute and involves Fox Chase and 11 other U.S. institutions.
“Proteomics offers significant hope as a cancer diagnostic tool, but while the earlier study appears promising, the results must be validated,” explained Mary Daly, M.D., Ph.D., a world-renown medical oncologist and co-investigator of the study at Fox Chase. “To do this, we’ll begin studying proteomics using blood from women who have had ovarian cancer to see if we can identify a specific protein pattern in those women whose cancers may later recur.” Over 80 percent of advanced-stage ovarian cancer patients in remission have recurrence of their disease.
Researchers say proteomics offers the future hope of allowing doctors to diagnose cancer at an early stage when it is most curable. In addition, proteomics could allow physicians to diagnose ovarian cancer without the need for a biopsy or surgery.
“As of now, the only way to confirm that a woman has ovarian cancer is to surgically remove the ovaries,” explained Mitchell Edelson, M.D., chief of the section of gynecologic oncology at Fox Chase and co-investigator of the study. “Before a new blood test can be offered as a way to detect ovarian cancer, we must first confirm that there is a pattern of proteins specific to ovarian cancer. Any test for ovarian cancer must be proven to be reliable and dependable so that women don’t get needless surgeries because of a false-positive result.”
The clinical trial also is open to women who have had peritoneal and fallopian tube cancers. Women in the study must have had Stage III or IV disease at diagnosis, and must have completed initial standard treatment within 12 weeks of enrolling in the proteomics study. Participants will be asked to give blood every three months for four years (unless the disease recurs). The results of the blood tests will not be given to the participants because an accurate protein pattern for ovarian cancer has yet to be determined.
Researchers nationwide hope to enroll 400 women in this study. As part of this study, physicians will monitor all women for recurrent disease in the same way as those who are not on this study. No anti-cancer treatment will be offered unless a cancer has recurred (as determined by current tests including a CT scan, CA-125 blood test or physical exam).
Fox Chase is the only institution in the tri-state area participating in the NCI sponsored study. To find out more about this study, please call 215-728-3672.
More information about proteomics can be found at:
www.nci.nih.gov/newscenter/pressreleases/ProteomicsOvarian and
www.nci.nih.gov/cancertopics/factsheet/proteomicsqa.
University of Pennsylvania Study Seeking Participants
The Abramson Cancer Research Institute at the University of Pennsylvania is an academic medical center, dedicated to excellence in both patient care and research. The doctors at the Hospital of the University of Pennsylvania, along with a company called IDM, Inc. (Immuno-Designed Molecules, Inc.), are studying patients with ovarian cancer in an attempt to find better ways to treat ovarian cancer. Unfortunately, we know that even patients who have achieved a remission after surgery and chemotherapy may still suffer recurrence of their cancer. Currently, there is no standard treatment to prevent recurrence.
The purpose of this study is to see if using a vaccine made from a patient’s own white blood cells can stimulate the body’s immune system to attack their cancer. The investigators will also be evaluating the vaccine’s safety. Though this particular vaccine has not been used in other clinical trials before, more than 350 patients with cancer have been treated with other types of vaccines and there have been no major side effects reported to date.
The investigators are actively seeking patients with the following criteria to participate in this study:
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Over age 18 with diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma.
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Currently in remission after treatment with surgery and chemotherapy for stage III or IV disease
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Patients who were diagnosed with any stage may also be eligible if they experienced at least a two year remission after the initial diagnosis, followed by a recurrence of the cancer which was then successfully treated by chemotherapy
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Time from completion of chemotherapy less than 6 months
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Patients must have a particular tissue type called HLA-A2, which may be checked with a blood test
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Patients may not have a history of other cancers within the past 5 years, except basal cell or squamous cell skin cancers
If you are interested in obtaining more information about the trial, free to contact the office of Dr. Christina Chu, (215) 662-3318, or her research nurse, Denise Bendig, BSN at (215) 746 3637.
Novartis Oncology Announces Phase 3 Trial Enrollment
Novartis Oncology is conducting a clinical research study to find out if the study drug patupilone, as compared to the drug pegylated liposomal doxorubicin, is safe, if it can extend the survival time longer than pegylated liposomal doxorubicin currently may and if it has any additional beneficial effects in people who have non-responsive or recurrent ovarian, primary fallopian or primary peritoneal cancer. Because we do not know which medicine is best, we need to make comparisons. Study participants may get either 10 mg/m2 patupilone once every three weeks or 50 mg/m2 of pegylated liposomal doxorubicin once every four weeks, intravenously (directly into a vein). Study participants will be randomly assigned by an automated system to receive either the study drug patupilone or pegylated liposomal doxorubicin. Patients will not have a choice of which medication they will receive. The study drug, Patupilone is a medicine which has not been approved by the FDA (US Food and Drug Administration) or the EMEA (European Medicines Agency) for the treatment of people with your medical condition.
Trial phase: Phase 3
Participation Durations: 1 hour visit to study site, every 3-4 wks for treatment and evaluations. After completion of study treatment, you will be asked to come to the study site every 3 months to see how you’re doing and follow the progress of your disease.
Protocol Number: CEPO906A2303
For more information regarding this trial as well as sites participating, please contact: www.clinicaltrials.gov – In the search box enter NCT00262990 or visit www.novartisclinicaltrials.com and select "Ovarian Cancer" or call the Novartis Oncology Clinical Trials Hotline at 800-340-6843.
NIH Seeks Participants in the Washington DC Area
The NIH is currently recruiting cancer survivors in the Washington DC area for a study examining the effectiveness of two different exercise programs in cancer survivors. For more information, please visit http://clinicalstudies.info.nih.gov/detail/A_2006-AT-0016.html.
Study Seeks Women to Investigate Perceptions of Genetic Testing
The University of Miami/Sylvester Comprehensive Cancer Center in conjunction with Jackson Memorial Hospital is conducting a research study to investigate women’s perceptions of genetic testing for breast and ovarian cancers.
To be included in this study and qualify to fill out a survey you must:
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Be female,
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Between the ages of 18 and 75
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Have a mother, sister, daughter, grandmother, or aunt that has been diagnosed with breast and/or ovarian cancer(s)
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Never have been personally diagnosed with cancer (other than skin cancer)
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Please be advised that genetic tests are NOT being performed nor are any blood draws. All Information provided is confidential.
For more information, please contact Dr. Frank Penedo, PI, at 305-284-6711 or Dr. Martha Martinez at 954-665-4325 or email mmartinez22@med.miami.edu.
The Hope Study
The University of Pittsburgh’s Graduate School of Public Health, Department of Epidemiology, and The University of Pittsburgh Cancer Institute has initiated a five-year program called The HOPE Project, an almost $5 million nationally funded research study on ovarian cancer. Led by principal investigators Roberta B. Ness, MD, MPH, and Francesmary Modugno, PhD, MPH, the project will involve interviews with 2,700 women in Western Pennsylvania, Eastern Ohio and Western New York.
The purpose of the study is to determine why certain women develop ovarian cancer and to use those findings to prevent the cancer or to detect it sooner. The earlier ovarian cancer is detected, the better the prognosis for patients. For instance, five-year survival rates after surgery are 95% if cancer is found while still inside the ovary, but only 20% once it has spread beyond the ovary. Unfortunately, for most women it often is found too late. Information collected from the study may identify factors that prevent ovarian cancer as well as factors that put women at risk for the disease.
Ovarian cancer affects about 1300 and kills almost 800 women a year in Pennsylvania. This represents about 5% of ovarian cancer cases and deaths in the United States, suggesting that Pennsylvania disproportionately bares the burden of the disease, likely due to its aging population.
"Ovarian cancer patients are such generous people. In helping with our study they are selflessly giving us information so that they can help others. These women want to help in the fight and protect their daughters and granddaughters,” said Dr. Modugno. “We’re learning more about risk factors every day. We need to understand why women get ovarian cancer so we can not only detect it earlier, but also prevent it altogether. If it’s found too late ovarian cancer can be fatal. We want to fix that."
Because it is often diagnosed at a late, incurable stage, ovarian cancer is called the “silent killer.” Advocacy groups like the National Ovarian Cancer Coalition (NOCC) work to educate women about the disease so that they can be diagnosed earlier. Julene Fabrizio, President-elect of the NOCC and current President of the Pittsburgh Division states, “This study is a great opportunity for a woman who has recently been diagnosed with ovarian cancer to participate in a study that will help researchers pinpoint that one element to give ‘hope’ in the search for conquering or detecting ovarian cancer,” In 2003 alone, eight members of the Pittsburgh Division lost the battle in their fight against ovarian cancer, including 2 of the 3 founding members.
The study involves a one-time, two-hour interview to obtain information on health and other related topics. Patients can choose to be seen at a centralized medical facility or in their homes.
In Pennsylvania alone, The HOPE Project will interview 300 recently diagnosed cancer patients. Anyone interested in participating in this study must meet the following criteria: